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CarboClear Cervical Cage / VBR System
CARBOFIX ORTHOPEDICS LTD · Model Implant Trial H=4 · UDI-DI 07290110208967
1
510(k) clearances
1,116
Adverse events (3 deaths)
11
Recalls
345
Facilities
Description
A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space, as applicable.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2020-09-30 | XTANT Medical | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
| 2013-10-07 | RTI Surgical, Inc. | As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ |
| 2013-02-05 | SpineNet | The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to |
| 2012-06-15 | Exactech, Inc. | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inter |
| 2011-09-23 | Synthes USA (HQ), Inc. | LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.